CardioVascular and Interventional Radiology

, Volume 42, Issue 2, pp 239–249 | Cite as

Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial

  • Konrad MohnikeEmail author
  • Ingo G. Steffen
  • Max Seidensticker
  • Peter Hass
  • Robert Damm
  • Nils Peters
  • Ricarda Seidensticker
  • Kerstin Schütte
  • Jörg Arend
  • Jan Bornschein
  • Tina Streitparth
  • Christian Wybranski
  • Gero Wieners
  • Patrick Stübs
  • Peter Malfertheiner
  • Maciej Pech
  • Jens Ricke
Clinical Investigation Interventional Oncology
Part of the following topical collections:
  1. Interventional Oncology


Background and Aims

The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma.


Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child–Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages.


Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27–0.89; p = 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29–0.85; p = 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33–1.16; p = 0.136).


This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.


Ablation Liver cancer BCLC HCC RCT 



American Association for the Study of the Liver


Barcelona Clinic Liver Cancer (staging system)


Confidence interval


Cancer of the Liver Italian Program


Computed tomography


Conventional transarterial chemoembolization


Common Terminology Criteria for Adverse Events


Drug-eluting beads transarterial chemoembolization


European Association for the Study of the Liver


Hepatocellular carcinoma


High dose rate


Hazard ratio


Interstitial brachytherapy


Overall survival


Portal vein thrombosis


Radiofrequency ablation


Stereotactic body radiotherapy


Time to progression


Time to untreatable progression



This study was funded exclusively by the University of Magdeburg.

Compliance with Ethical Standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for Publication

Consent for publication was obtained for every individual person’s data included in the study.

Financial Support

This work was funded exclusively by the University of Magdeburg.

Ethical Considerations

The study was conducted in accordance with the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and ICH-GCP. The study protocol and all study-related documentation were approved by all relevant authorities (Ethics Committee of the Medical Faculty, University of Magdeburg, 44/06).


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2018

Authors and Affiliations

  • Konrad Mohnike
    • 1
    • 11
    • 12
    Email author
  • Ingo G. Steffen
    • 2
  • Max Seidensticker
    • 3
    • 12
  • Peter Hass
    • 4
  • Robert Damm
    • 1
  • Nils Peters
    • 11
  • Ricarda Seidensticker
    • 3
    • 12
  • Kerstin Schütte
    • 5
  • Jörg Arend
    • 6
  • Jan Bornschein
    • 7
  • Tina Streitparth
    • 3
  • Christian Wybranski
    • 8
  • Gero Wieners
    • 3
  • Patrick Stübs
    • 9
  • Peter Malfertheiner
    • 10
  • Maciej Pech
    • 1
    • 12
  • Jens Ricke
    • 3
    • 12
  1. 1.Department of Radiology and Nuclear MedicineUniversity of MagdeburgMagdeburgGermany
  2. 2.Department of RadiologyCharitéBerlinGermany
  3. 3.Department of RadiologyLuwig-Maximilians-University MunichMunichGermany
  4. 4.Department of RadiotherapyUniversity of MagdeburgMagdeburgGermany
  5. 5.Nils-Stensen-HospitalOsnabrueckGermany
  6. 6.Department of SurgeryUniversity of MagdeburgMagdeburgGermany
  7. 7.Translational Gastroenterology UnitOxford University HospitalsOxfordUK
  8. 8.Department of RadiologyUniversity Hospital of CologneCologneGermany
  9. 9.DRK-Hospital Berlin-KoepenickBerlinGermany
  10. 10.Department of Gastroenterology, Hepatology and InfectiologyUniversity of MagdeburgMagdeburgGermany
  11. 11.Diagnostisch Therapeutisches Zentrum am Frankfurter TorBerlinGermany
  12. 12.Deutsche Akademie für Mikrotherapie e.V.MagdeburgGermany

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